Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Prospective Multicenter Study Comparing Endobronchial and Endoscopic Ultrasound-Guided FNA to Mediastinoscopy/Thoracoscopy in the Staging and Early Detection of Metastases in Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00970645
• Other study ID #: 09-002240
• Secondary ID: DOD protocol A-1
• Status: Terminated
• Phase: N/A
• First received: September 1, 2009
• Last updated: July 15, 2011
• Start date: February 2010
• Est. completion date: March 2011

Study information

• Verified date: July 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized clinical trial with the study cohort comprised of all male and female patients over the age of 21 presenting to the study site for evaluation of lung cancer. The study will enroll 300 subjects, with 150 in each arm. Three sites will be in the study, Mayo Rochester, Mayo Jacksonville and Medical University of South Carolina. Mayo Rochester will enroll approximately 125 subjects. This study does not require subjects to undergo any additional procedures than what they would receive per standard medical care. The consenting subjects will receive EUS and /or EBUS- guided FNA or Mediastinoscopy/Thoracoscopy.

Description:

This is a prospective randomized clinical trial of males and females age 21 or older being evaluated for lung cancer. The study will enroll approximately 300 subjects (150 in each arm) at 3 participating centers (MUSC, Mayo Clinic Rochester and Jacksonville). This sample size will provide sufficient statistical power (i.e. >80%) using a non-inferiority study design with 1-sided hypothesis testing (Farrington and Manning 1990) to determine whether or not the sensitivity of the EUS/EBUS diagnostic technique is inferior (i.e. 10% or more lower) when compared to the sensitivity of malignant mediastinal adenopathy of about 40%. This study requires subjects to agree to the selection of their standard of care procedure. Subjects will be randomized (stratified computer generated randomization stratified y center and y CT positivity for pathologically enlarged [>1cm short axis] node - 10 strata). Randomization will use variable block sizes (4-8), so that randomization allocation remains concealed as investigators will not be blinded. This study requires subjects to consent to the release of outcome data and follow-up data to be used for study analysis. No additional visit will be required for this study; this study will not require any additional time requirements beyond their scheduled evaluations.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age 21 years or greater

• Pt is a surgical candidate for mediastinoscopy, thoracoscopy, or lung resection

• Known or suspected non-small cell carcinoma of the lung eligible for resection

• CT scan performed within 45 days prior to evaluation for study participation

• PET scan performed within 45 days prior to evaluation for study participation

Exclusion Criteria:

• Pathologically proven metastatic disease

• History of malignancy within 5 years other than (skin) basal cell carcinoma

• Enlarged ipsilateral mediastinal lymph nodes > 2.5 cm in diameter

• Peripheral T1 tumors with normal mediastinal lymph nodes on CT and PET

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Procedure:
• Mediastinoscopy/thoracoscopy
Mediastinoscopy used to detect/stage lung cancer.
• EBUS/EUS
Minimal invasive technique to stage/detect lung cancer.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Develop an integrated staging technique to detect early metastases in lung cancer which should affect patient outcomes more accurately than conventional staging techniques.		Post operative	No